BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2210431 · Received August 9, 2011

    Report

    Report Number
    1627487-2011-03403
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED A SCS SYSTEM ON (B)(6) 2007. IT WAS REPORTED THAT THE PT HAS NOT USED STIMULATION FOR 2 YEARS. THERE WAS NO COMMUNICATION WITH THE CHARGER. THE IPG WAS REPLACED WITH AN EON MINI IPG. THE STIMULATION WAS CAPTURED POSTOPERATIVE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 85673

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention